The following data is part of a premarket notification filed by Meretek Diagnostics, Inc. with the FDA for The Meretek Ubt Breath Test For H.pylori.
| Device ID | K972352 |
| 510k Number | K972352 |
| Device Name: | THE MERETEK UBT BREATH TEST FOR H.PYLORI |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | MERETEK DIAGNOSTICS, INC. 618 GRASSMERE PARK DRIVE, SUITE 20 Nashville, TN 37211 |
| Contact | Claudia T Hitchcock |
| Correspondent | Claudia T Hitchcock MERETEK DIAGNOSTICS, INC. 618 GRASSMERE PARK DRIVE, SUITE 20 Nashville, TN 37211 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-24 |
| Decision Date | 1997-10-29 |
| Summary: | summary |